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The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has collectively resulted in an improvement in rational prescribing for children, including more than 500 labeling changes. However, off-label drug use remains an important public health issue for infants, children, and adolescents, because an overwhelming number(More)
Part of the Therapeutics Commons This Article is brought to you for free and open access by the Jefferson Digital Commons. The Jefferson Digital Commons is a service of Thomas Jefferson University's Center for Teaching and Learning (CTL). The Commons is a showcase for Jefferson books and journals, peer-reviewed scholarly publications, unique historical(More)
BACKGROUND Enzymes of the cytochrome P450 3A (CYP3A) family are responsible for the metabolism of >50% of currently prescribed drugs. CYP3A5 is expressed in a limited number of individuals. The absence of CYP3A5 expression in approximately 70% of Caucasians was recently correlated to a genetic polymorphism (CYP3A5*3). Because CYP3A5 may represent up to 50%(More)
OBJECTIVES To evaluate the safety and tolerability of treatment with levetiracetam and determine the trough levels of levetiracetam in patients with traumatic brain injury (TBI) who are at high risk for posttraumatic epilepsy (PTE). DESIGN Open-label, nonrandomized phase 2 study with 2 arms comparing levetiracetam treatment vs observation. SETTING Two(More)
BACKGROUND Fear of infection in neonatal intensive care units (NICUs) often leads to early use of empiric broad-spectrum antibiotics, a strategy that selects for resistant bacteria. We investigated whether the emergence of resistant strains could be halted by modifying the empiric antibiotic regimens to remove the selective pressure that favours resistant(More)
abstract In 2009 we reported the fatal case of a toddler who had received co-deine after adenotonsillectomy for obstructive sleep apnea syndrome. The child was an ultra-rapid metabolizer of cytochrome P4502D6 (CYP2D6). We now report 3 additional fatal or life-threatening cases from North America. In the 2 fatal cases, functional gene duplications encoding(More)
and were mainly dermatological and liquid preparations. The table shows the official labelling of drugs prescribed for children. In 21.3% of the prescriptions for licensed drugs, use in children was not mentioned in the summary, and 19.7% mentioned use in children but without any indication of age. Although the summaries of remaining drugs indicated age,(More)
OBJECTIVE The objectives of this study were (1) to determine the effects of gestational age on ceftazidime pharmacokinetics in the preterm infant, (2) to relate these effects to changes in glomerular filtration rate (GFR), and (3) to establish appropriate dosage recommendations for preterm infants on day 3 of life. METHODS Multiple-dose pharmacokinetics(More)
OBJECTIVE To evaluate the single dose pharmacokinetics of an intravenous dose of lorazepam in pediatric patients treated for status epilepticus (SE) or with a history of SE. STUDY DESIGN Ten hospitals in the Pediatric Emergency Care Applied Research Network enlisted patients 3 months to 17 years with convulsive SE (status cohort) or for a traditional(More)